MAUDE Adverse Event Report: KENMEX NS-3631 N-STER DISPOSABLE; LITE HANDLE COVER

Model Number 31159422

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/27/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with lite handle covers.The customer reports that the lite handle covers are cracking and splitting.

• Brand Name: NS-3631 N-STER DISPOSABLE
• Type of Device: LITE HANDLE COVER
• Manufacturer (Section D): KENMEX; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5980171
• MDR Text Key: 56008507
• Report Number: 9612030-2016-00472
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31159422
• Device Catalogue Number: 31159422
• Device Lot Number: 600636464X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1